TMF Lead I

🔥 1 minute ago

🇷🇸 Serbia – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 21%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Ensure timely, high-quality TMF document review, processing, periodic quality review, setup, maintenance, finalization, and archival • Create and execute study TMF Plans and project TMF Document Indexes • Communicate TMF expectations, project-specific requirements, and changes to study teams • Attend and contribute to project kick-off, internal, external, and ad hoc meetings • Collaborate with Project Managers and Functional Leads to maintain inspection-ready TMFs • Identify TMF compliance challenges, risks, gaps, and non-compliance; develop and implement mitigation plans • Monitor and report TMF health, metrics, trends, risks, and overall status • Serve as point of contact and Subject Matter Expert for project audits and inspections • Provide TMF analytics and expertise to sponsors • Ensure periodic quality reviews and document processing are completed for assigned projects • Identify TMF training needs and provide or support team re-education • Manage study close-out activities, including final document submission, query close-out, eTMF export, sponsor transfer, and receipt acknowledgement • Manage projects within sponsor eTMF systems • Monitor and report potential out-of-scope Records Management activities and support change orders • Support and mentor less experienced TMF Leads

🎯 Requirements

• Bachelor’s degree (or its international equivalent) +5 years of related experience, or equivalent combination of education, professional training and experience • Working knowledge of FDA and ICH/GCP regulations and guidelines • Ability to identify issues and escalate appropriately and effectively • Excellent organizational skills and time management • Ability to coordinate workload and meet established deadlines • Ability to manage competing priorities effectively • Working knowledge of relevant Precision SOPs and regulatory guidance, or ability to be trained and retain this knowledge • Detail-oriented and able to work and plan independently and in a team environment • Professional verbal and written communication skills • Candidates must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities • AI opt-out request available during the application process

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